Influenza is a common infectious disease brought about by an RNA virus of the same name. While vaccines for influenza have been available, strains of influenza evolve readily and novel viruses emerge from various species (e.g. bird to human transfer) requiring new vaccines to be provided on seasonal or sporadic basis. Similarly, other disease causing agents including various viruses such as HIV, HTLV viruses and others evolve readily and novel viruses emerge from various species (e.g. bird, rodents, livestock and other primate-to-human transfer) requiring new vaccines to be provided on seasonal or sporadic basis. Whole virus vaccines, split virus vaccines, surface antigen vaccines and live attenuated virus vaccines are available for influenza. However, presently available vaccines require constant updating because of 1) mutations, 2) re-assortment of genes between various strains, and 3) the continual emergence (or re-emergence) of different strains.
Common vaccines for influenza are designed to induce an immune response that is directed at the so-called protective antigens, hemagglutinin (HA or H) and neuramindase (NA or N), and the vaccines induce strain specific immunity.
Each year, numerous individuals are infected with different strains and types of influenza virus. Oftentimes, complications from influenza infection lead to protracted illness or death. Infants, the elderly, those without adequate health care and immuno-compromised persons are particularly vulnerable to complications arising from influenza infections. In some cases, otherwise healthy adults are at risk for severe complications including death from influenza infection. The 1918 Spanish influenza, which was genetically related to the 2009 pandemic H1N1 influenza, had the propensity for affecting individuals with healthy immune systems. The H5N1 influenza virus is also believed to have a heightened risk for affecting individuals with healthy immune systems, which may result in a cytokine storm (hypercytokimemia). A cytokine storm is caused by excessive amounts of pro-inflammatory cytokines and tends to occur in patients with stronger, “robust,” immune systems and leads to an increased risk for death in otherwise healthy adults. There is a need for a formulation and a method of vaccination and/or treatment to combat a deadly pandemic and to protect against new strains of Type A influenza that may present an elevated risk for even those with healthy immune systems. Emergent influenza viruses can be the most deadly for people in their prime, rather than affecting only the very young, the very old, or the most severely immuno-compromised.
Appropriate formulations of peptide constructs can stimulate and produce a systemic immune response. Peptide construct technology has provided the ability to produce vaccines using genetic engineering (recombinant vaccines). Such vaccines are typically created using antigenic moieties of the newly emergent virus strains when polypeptides and polynucleotides of novel, newly emergent, or newly re-emergent virus strains are desired. The focus on most current vaccines is not on conserved proteins and, especially, essential regions of such conserved proteins.